This study is looking at adults who have Major Depressive Disorder, which is a mental health condition that causes persistent feelings of sadness and loss of interest in daily activities. Some people with this condition may also experience anxious distress, which means they feel worried, tense, or restless along with their depression. The treatment being tested is called SPT-300, which is given as a capsule taken by mouth. The active ingredient in this medication is brexanolone caprilcerbate. The purpose of this study is to check how safe this medication is and whether people can tolerate it well when they take it over a period of time.
This is an extension study, which means it is designed for people who have already completed another study with the same medication. Participants will take SPT-300 for six weeks, and everyone in the study will receive the active medication rather than a placebo. The study is described as open-label, which means both the participants and the doctors will know what treatment is being given. During the study, participants will have regular visits where doctors will check for any unwanted effects, measure vital signs like blood pressure and heart rate, and perform blood tests and physical examinations. The doctors will also use questionnaires to assess mood, anxiety levels, and how the condition affects daily life.
Throughout the six weeks, the medical team will carefully monitor participants for any side effects or health changes. Special attention will be given to thoughts of self-harm using a specific rating scale designed for this purpose. The study will also look at whether symptoms of depression and anxiety improve over time. Participants will need to avoid alcohol and recreational drugs during the study and must use effective birth control methods if they are able to have children. The maximum daily dose of the medication is 375 milligrams, and treatment will continue for the full six-week period.
Bulgaria 
Czechia 
Germany 
Hungary 
Poland 
Romania 
Slovakia 
